Fierce Pharma Asia—Serum Institute fire; 2nd Enhertu FDA nod; more Fujifilm expansion

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A major fire at the Serum Institute of India’s Pune facility killed five people, while its production of AstraZeneca’s COVID-19 vaccine was unaffected. Daiichi Sankyo and AZ’s Enhertu won its second FDA nod for the treatment of previously treated stomach cancer. On an expansion spree, Fufjifilm has laid out a plan for a new $76 million R&D and manufacturing site in the Boston area. And more.

1. Fire at Serum Institute’s vaccine manufacturing site kills 5 (BBC)

A major fire killed five people at the Serum Institute of India’s (SII’s) vaccine manufacturing facilities in the western Indian city of Pune. The fire happened at a newly constructed building, which includes lab spaces for rotavirus and BCG vaccines. SII is AstraZeneca’s production partner on its COVID-19 vaccine candidate, known locally as Covishield, for low- and middle-income countries. “I would like to reassure all governments & the public that there would be no loss of #COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies” at SII, CEO Adar Poonawalla said in a tweet.

2. AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer OK

Daiichi Sankyo and partner AstraZeneca won FDA approval for Enhertu in HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s Herceptin. Enhertu cut the risk of death by 41% over chemotherapy in phase 3 trial patients who had progressed on at least two previous treatments. The antibody-drug conjugate is a key pillar in Daiichi’s ambition of achieving JPY500 billion ($5 billion) in peak oncology sales.

3. Fujifilm continues CMDO expansion spree with $76M in funding for new Boston site

A $40 million new viral vector plant and a massive, $2 billion cell culture production site aren’t the only expansions Fujifilm has in mind. The Japanese company, together with The Massachusetts Center for Advanced Biological Innovation and Manufacturing, have put forward $76 million for a 40,000-square-foot site in Watertown. The new facility will support R&D as well as manufacturing work in cell and gene therapy, gene editing, immunotherapy and biotechnology.

4. Adagene plans $125M IPO to go after cancer niches targeted by BMS and Pfizer

Chinese biotech Adagene has filed to raise up to $125 million in a Nasdaq IPO. The company is designing drugs targeting unique binding sites on proteins of interest in cancer. Its most advanced programs include antibodies that target CD137 and CTLA-4.

5. Sinopharm claims COVID-19 vaccine safe in kids aged 3 and up

A clinical trial found a COVID-19 vaccine by Sinopharm’s CNBG to be safe in children aged 3 to 17 years, according to China’s state-run Xinhua. “It should be noted that for 3- to 5-year-old children, because their immune system is still developing, they must be carefully and closely monitored during vaccination,” CNBG Chairman Yang Xiaoming was quoted as saying. CNBG has two inactivated vaccines, and this appears to be the one developed by its Beijing research institute—the same one Chinese authorities conditionally approved at the end of 2020.

6. Samsung eyes manufacturing expansions into U.S. and beyond as work on Korean ‘Super Plant’ plows ahead

Samsung Biologics has a $2 billion “Super Plant” in the works in Incheon, South Korea, but the CDMO is also eyeing manufacturing pushes into the U.S., Europe and eventually, China, newly minted CEO John Rim said at the annual J.P. Morgan healthcare conference. The company’s looking to transfer existing orders to the massive plant and lock in new clients early before its expected 2023 completion date.

Aurinia snags FDA approval for lupus nephritis med Lupkynis, its first drug launch

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Aurinia has nabbed its first FDA approval with an OK for Lupkynis (voclosporin) to treat lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus. And now it’ll look to its newly bolstered commercial team to take the drug into a wide-open market.

The FDA late Friday green-lighted Aurinia’s drug, a calcineurin inhibitor that blocks IL-2 protein inflammation and stabilizes kidney cells that can be damaged in patients who have advanced lupus nephritis.

In its phase 3 trial, patients who received Lupkynis, rather than placebo, on top of standard immunosuppressants had a higher renal response rate at 52 weeks. Aurinia also reported statistically significant results against a clutch of secondary endpoints, showing Lupkynis started outperforming placebo within 24 weeks and brought the urinary protein-to-creatinine ratio down faster.

RELATED: Aurinia soars as phase 3 lupus study hits primary endpoint

Aurinia estimates that of the half-million lupus patients in the U.S., about 80,000 to 100,000 progress to lupus nephritis, which can lead to kidney failure, dialysis, transplant and even death. The company estimates a similarly sized group of potential patients in Europe.

“We’re excited to bring a drug with great data to the market and bring a new drug to Aurinia, but more importantly bring a new product to this patient population that really hasn’t had anything up until this point,” Aurinia President and CEO Peter Greenleaf said.

Aurinia spent 2020 building its commercial operations, boosting employees from fewer than 50 to now more than 300, concentrating on the U.S., Greenleaf said. About 100 to 150 of those are customer-facing sales and medical team reps. The pharma also signed a deal with Otsuka Pharmaceuticals to market Lupkynis globally, beginning in Europe and Japan.

The initial targets are rheumatologists and nephrologists, whom Aurinia reps have already been talking to and supplying with educational materials for several months, Greenleaf said. That effort includes an HCP-targeted disease awareness campaign, “Time Is Nephrons.”

Among that group, Aurinia has “good wind in our sails” as those doctors generally agree that aggressive treatment to reduce protein-to-creatinine ratios in lupus nephritis patients is needed, he said.

RELATED: GSK fires up ‘Smolder’ lupus awareness campaign to remind docs of potential organ damage

Aurinia’s nod follows on the heels of a go-ahead for GlaxoSmithKline’s Benlysta, which received a supplemental biologic license to treat lupus nephritis in December. Benlysta was approved in 2011 and is the sole biologic approved to treat systemic lupus erythematosus.

So while Aurinia’s Lupkynis will compete with the broader Benlysta, it has an advantage that the pharma plans to highlight with doctors and patients. Lupkynis begins working faster, Greenleaf pointed out; Benlysta’s lupus nephritis data showed a primary efficacy renal response at two years.

Meanwhile, though, more competition is on the horizon as Roche studies blood cancer med Gazyva in lupus nephritis specifically and AstraZeneca trials anifrolumab in systemic lupus erythematosus.

GlaxoSmithKline’s ‘serial disappointments’ cast doubt on its growth plans: analyst

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Between the failure of its late-stage cancer drug bintrafusp alfa in a key clinical trial and an unexpected inspection delay for another oncology hopeful, dostarlimab, GlaxoSmithKline is having a bad week, to say the least.

But some pharma analysts worry that those problems are more than just short-term blips. They raise questions about GSK’s dealmaking and cast doubt on its forecasts, they said.

SVB Leerink’s Geoffrey Porges went so far as to say GSK’s five-year roadmap, which Chief Scientific Officer Hal Barron, M.D., presented last week at the JPMorgan Healthcare Conference, may already be in jeopardy. That’s because Barron promised more than 10 potential blockbuster launches by 2026—two of which are bintrafusp alfa and dostarlimab.

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“Notwithstanding GSK’s attractive valuation, these serial disappointments are becoming a major concern for GSK’s medium- and long-term outlook,” Porges said in a note to investors.

Three years ago, GSK CEO Emma Walmsley launched a major makeover that included forming a consumer joint venture with Pfizer—now in the process of being spun off into an independent company—and ramping up investments in its pharmaceutical portfolio. One of those investments was a €300 million up-front deal in 2019—worth $4.6 billion total—with Merck KGaA to develop bintrafusp alfa.

The immuno-oncology drug, which fuses a TGF-β trap with an anti-PD-L1 molecule, failed a trial comparing it to Merck & Co.’s blockbuster PD-1 inhibitor Keytruda in non-small cell lung cancer (NSCLC). An independent monitoring committee told GSK the trial is unlikely to meet its primary endpoint, prompting GSK and Merck KGaA to call a halt.

RELATED: GSK, German Merck’s $4.2B bintrafusp alfa drug a bust, fails to beat king Keytruda in lung cancer

Bintrafusp is still in trials for biliary track cancer and cervical cancer, but a recent small trial in MSI-high tumors was disappointing, SVB Leerink’s Porges said, raising doubts about the drug’s future. “Although the ‘new GSK’ does not have a long history, so far the company’s capital allocation process and results aren’t inspiring confidence,” the note said.

GSK was expecting the FDA to rule on its other near-term oncology hopeful, dostarlimab, by the end of last year. But COVID-19 travel restrictions prevented an inspection of the manufacturing facility, GSK said earlier this week, and that inspection still hasn’t been scheduled. Analysts are still expecting the FDA to clear the PD-1 blocker to treat MSI-high and microsatellite stable (MSS) endometrial cancer, and a decision is due in the first half of this year, the company said.

Vaccines are another key growth area for GSK, with 16 in the pipeline. But there have been some hiccups there, too. Sales of the company’s high-profile shingles vaccine, Shingrix, fell 25% in the third quarter of last year as Americans delayed the shot amid COVID-19 lockdowns. GSK’s vaccine unit posted the company’s biggest sales decline of 9%.

RELATED: GSK’s vaccines—especially Shingrix—typically drive growth. Amid COVID-19, they’re a drag

Credit Suisse analysts predicted another hurdle for Shingrix in the short term: The Centers for Disease Control issued guidance suggesting COVID-19 vaccines should not be given with other vaccines. That will “significantly limit” sales of Shingrix in the first half of 2021, Credit Suisse said in a note to investors.

Credit Suisse downgraded its rating of GSK to “underperform,” noting that the company is facing so many challenges it may need to cut its 2022 dividend by more than 35%. “With multiple near-term and strategic challenges we see limited upside,” Credit Suisse said.

Novo Nordisk, following in Lilly’s Trulicity footsteps, files higher Ozempic dose for diabetes

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Novo Nordisk and Eli Lilly are locked in a tough fight, both vying for the top spot in the GLP-1 diabetes treatment class. On strategy they’ve both pursued is increasing the dosing of their existing offerings to reach better efficacy. Now, Novo has made its regulatory move.

Wednesday, the Danish company said it had filed for U.S. approval of once-weekly Ozempic at a new dose of 2.0 mg. The GLP-1 analogue currently comes at two lower doses of 0.5 mg and 1.0 mg. It submitted the same label extension request to EU regulators in late December.

The news came after Lilly in September secured a U.S. nod for rival once-weekly GLP-1 drug Trulicity to include 3.0 mg and 4.5 mg doses on top of the original 1.5 mg offering.

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Both drugs have shown they work better in diabetes patients when given at higher doses. For Ozempic specifically, in the phase 3b Sustain Forte trial, the 2.0-mg dose showed a statistically significant reduction in blood sugar levels compared with the 1.0-mg dose at week 40. More patients on the high dose achieved the American Diabetes Association treatment target of HbA1c—a commonly used metric for blood sugar—below 7%. The high-dose takers also lost more bodyweight than their low-dose counterparts did.

RELATED: Lilly’s Trulicity slips as COVID-19 insurance changes trigger price declines

Ozempic’s been growing aggressively since its launch in 2018 as Lilly’s earlier-to-market Trulicity plays defense, even though the entire GLP-1 share in the diabetes market continues to increase thanks to the two drugs.

As of 2020’s third quarter, the two drugs were neck and neck in terms of U.S. new-to-brand share, with Ozempic at 34.7% and Trulicity 34.5%. Total scripts share was 44.3% for Trulicity, versus 26.8% for Ozempic.

But the focus at Novo Nordisk these days also includes newly launched Rybelsus, an oral drug that shares injectable Ozempic’s active ingredient, semaglutide. Approved by the FDA in September 2019, the drug is viewed as a market disrupter.


Novo’s Rybelsus launch is on the up-and-up after taking pandemic hit: execs

Merely 20 weeks into its launch, Rybelsus enjoyed new-to-brand share that matched that of the entire SGLT2 class, which also consists of oral medications. While its share slipped during the first few months of the COVID-19 pandemic, it has returned and been ticking upward as lockdowns lift. More good news for Novo: Over 80% of the drug’s new scripts went to patients new to the GLP-1 class, CEO Lars Fruergaard Jørgensen said during a call in October.

During the third quarter of 2020, Novo also launched a phase 1 trial testing higher doses of oral semaglutide for diabetes.

Combined, Novo’s GLP-1 franchise, which also includes old stalwart Victoza, generated sales of DKK30.05 billion ($4.9 billion) during the first nine months of 2020, with Ozempic contributing half of that. By contrast, Lilly’s Trulicity hauled in sales of $2.9 billion during the same period after 22% year-over-year growth.


Lilly’s tirzepatide drives deep drops in blood sugar and body weight in diabetes phase 3

Novo’s ambitions for semaglutide lie beyond diabetes. Last month, the company filed a 2.4 mg, once-weekly version of the under-the-skin drug to the FDA as an obesity treatment after showing weight loss of around 15% to 18% across three phase 3 trials.

The drug also recently showed promise in non-alcoholic steatohepatitis (NASH) in a phase 2 trial, though industry watchers mostly expect it to be able to help earlier-stages patients but not those with heavier liver fibrosis. In a more surprising move, Novo unveiled in mid-December that it would launch a phase 3 trial of oral semaglutide in Alzheimer’s disease.

Lilly has its countermeasure taking shape, too. Its GIP and GLP-1 dual agonist tirzepatide just nailed a phase 3 trial in diabetes, showing significant improvements in blood sugar levels and body weight that were superior to placebo’s data. But both Lilly and Novo, as well as industry watchers, will be more interested in the readout from a second phase 3 trial dubbed Surpass-2, which pits tirzepatide against Ozempic.

Good news for shot-makers: COVID-19 vaccine confidence leaps to 69%, Harris Poll finds

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Americans are back on the COVID-19 vaccine bandwagon. Sixty-nine percent now plan to get a COVID-19 vaccine, close to the previous high of 73% in April, according to the latest data from The Harris Poll.

At the lowest point in October, vaccine skepticism had far more Americans hesitating: Just 58% said they would get a vaccine.

That’s good news for vaccine makers—and at least a little better news for public health officials, who say a minimum 75% of the population will need to be vaccinated to stop COVID-19. That percentage has been moving upwards of late; Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), recently admitted the goal may need to move as high as 90% to truly halt the U.S. outbreak.

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RELATED: Pharma’s reputation gains persist through pandemic, bolstered by vaccine makers’ pledge: Harris Poll

The uptick comes as both vaccine makers with emergency use approval, Moderna and Pfizer/BioNTech, launch vaccine marketing and awareness campaigns. Pfizer and BioNTech’s initial effort focuses on reminding people about their pre-pandemic lives, while Moderna is striking up partnerships, including one with Uber, to raise awareness.

The federal government is also working to promote COVID-19 vaccines. The Biden administration has pledged a locally-focused public education campaign using trusted voices to encourage vaccine uptake. Meanwhile, the Department of Health and Human Services (HHS) is in the first phase of its $250 million campaign to shore up vaccine confidence and encourage ongoing safety measures.

The feds’ local goal will likely be necessary. Harris numbers show the intention to get a vaccine breaks down differently among age groups and demographics. Both vaccine makers and the government will have to tailor messages and target media to a variety of groups.

For instance, among people aged 65 and older, 82% say they are likely to get vaccinated. The intention is lowest among 18-34-year-olds; only 59% of them say they will, Harris’ most recent data reveals.

RELATED: Black Americans more skeptical than ever about COVID-19 vaccine: Harris Poll

Still, that’s not necessarily bad news. The younger generations’ vaccine attitude has more to do with apathy than antipathy, said Rob Jekielek, managing director at The Harris Poll. In general, the younger cohort would be likely to get a vaccine if required—to go to college, for instance.

A bigger and potentially more worrisome gap remains between white and Black Americans. While 72% of white people say they are likely to get a vaccine, only 58% of Black people agree. Lower trust in healthcare information sources, such as doctors and nurses, and pharma companies likely contributes to Black Americans’ lower inclination to take a vaccine.

Emergency workers save Wockhardt fill-finish plant—and AstraZeneca COVID-19 vaccine doses inside—from rising floodwaters

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Limited supplies, spotty logistics and now a deluge. After contending with plenty of other problems, the  U.K.’s coronavirus vaccine rollout faced yet another threat Wednesday night when a Wockhardt plant faced rising water.

Emergency teams worked through the night as floodwaters from Storm Christoph surrounded buildings at Wockhardt’s manufacturing facility in Wrexham, North Wales, under contract to help produce AstraZeneca’s COVID-19 vaccine, The Irish News reports.

Wockhardt, an India-based drugmaker with footprints in the U.S., the U.K., Ireland and France, agreed in August to carry out fill-finish work on millions of COVID-19 vaccine doses for exclusive use in the U.K. Central to that deal is AstraZeneca’s shot—now approved in the U.K.—which Wockhardt is filling and finishing at its Wrexham site.

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Wockhardt’s Wrexham storage facility faced a particular risk of flooding, putting finished vaccine supplies for Wales and the U.K. as a whole in jeopardy. Emergency services quickly mobilized, establishing resources like gullies to protect the warehouse, Mark Pritchard, leader of Wrexham County Borough, said.

RELATED: Valneva signs $1.6B supply, development agreement with U.K. for coronavirus vaccine hopeful

In the end, all “necessary precautions were taken, meaning no disruption to manufacturing or inlet of water into buildings” occurred, a Wockhardt spokesperson told The Irish News. “The site is now secure and free from any further flood damage and operating as normal.”

AstraZeneca’s vaccine was cleared for emergency use in the U.K. at the tail end of 2020, joining Pfizer and BioNTech’s mRNA shot, which Britain OK’d in early December. The British Big Pharma aims to supply “millions” of doses in 2021’s first quarter as part of a larger deal to provide the U.K. with up to 100 million shots.

RELATED: AstraZeneca CEO blames trial delays, not manufacturing, for COVID-19 vaccine delivery shortfall

Meanwhile, as Britain grapples with repeat lockdowns and a fast-spreading variant of SARS-CoV-2, the virus that causes COVID-19, the country is making good on plans to vaccinate 15 million of its most vulnerable citizens by mid-February, The Washington Post reported.

More than 4 million people from that group, or about 8% of the U.K.’s adult population, have received a first shot. Among those are nearly half of the 300,000 nursing home residents who can’t travel to get a vaccine; mobile vaccination teams using AstraZeneca’s shot, which British doctors tout as easier to store and prepare than Pfizer’s vaccine, have proven central to those efforts, the Post said. 

US approval for MSD’s heart failure med Verquvo

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The Food and Drug Administration (FDA) in the US has approved MSD’s (known as Merck in the US and Canada) heart failure treatment Verquvo (vericiguat).

Verquvo has been approved to reduce the risk of cardiovascular death and heart failure hospitalisation, following a hospitalisation for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

The approval is based on the results from the Phase III VICTORIA trial, Verquvo met the primary efficacy objective based on a time-to-event analysis.

Over the duration of the study, investigators observed a 4.2% reduction in annualised absolute risk of cardiovascular death or heart failure hospitalisations compared to placebo.

“Verquvo has been shown to reduce the risk of cardiovascular death and heart failure hospitalisation following a hospitalisation for heart failure or need for outpatient IV diuretics. said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease,” he added.

According to MSD, the FDA approval of Verquvo makes it the first treatment for chronic heart failure approved specifically for patients following hospitalisation for heart failure or need for outpatient IV diuretics.

RCP survey finds over 1 in 4 doctors sought mental health support during pandemic

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A new survey from the Royal College of Physicians (RCP) has found that almost a fifth of its members had sought informal mental health support during the COVID-19 pandemic.

In addition, 10% of respondents said that they had sought formal mental health support from either their employer, GP or external services.

A third of respondents also reported feeling supported (35%) and determined (37%), although a large number of doctors (64%) reported feeling tired or exhausted and worried (48%).

In regards to the second wave of coronavirus currently hitting the NHS, 56% of respondents said that they were ‘very concerned’ about the impact of rising COVID-19 admissions on their organisations capacity to continue to deliver safe and effective care.

“These survey findings are sadly far from surprising, given the monumental pressures on the NHS workforce right now, with record numbers of patients in hospitals with coronavirus and about 53,800 staff away from work for reasons related to the virus, all while we are rolling out the largest ever mass vaccination programme,” said Rebecca Smith, managing director of NHS Employers.

“The dedication and commitment of all NHS staff to keep going during this COVID emergency should not be understated, but this way of working is clearly unsustainable, and an honest conversation will be needed about how quickly the NHS can spring back once this peak subsides,” she added.

NICE publishes final guidance backing Jyseleca for rheumatoid arthritis

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The National Institute for Health and Care Excellence (NICE) has published its final appraisal determination (FAD) recommending the use of Gilead Sciences and Galapagos’ Jyseleca (filgotinib) for the treatment of rheumatoid arthritis (RA).

The FAD means that the daily oral pill will now be available on the NHS in England for the treatment of eligible adults patients with moderate-to-severe active RA.

To be eligible, patients with moderate-to-severe RA will have had an inadequate response to intensive therapy with two or more disease-modifying anti-rheumatic drugs (DMARDs).

Over 400,000 people in the UK live with RA – a degenerative auto-immune disease that can potentially cause life-threatening complications.

The NICE recommendation for Jyseleca marks the first time in the UK that an advanced therapy has been made available to people with moderate RA.

“Being able to get the debilitating symptoms under control and ideally into remission, can be life changing and it is vital that people have the best chance of achieving this before it’s too late and permanent damage is done,” said Clare Jacklin, chief executive of the National Rheumatoid Arthritis Society (NRAS).

“For many, this [recommendation] could mean remaining in or getting back to work, fully enjoying family life or just getting on with simple things that many of us so often take for granted.  Having an opportunity for earlier intervention will lead I hope to many living a life unburdened by RA,” she added.

Pfizer, BioNTech’s COVID-19 vaccine likely to be effective against UK strain

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Pfizer and BioNTech have announced the publication of results showing that their COVID-19 vaccine is likely to be effective against the SARS-CoV-2 strain found in the UK.

The strain, also known as the B.1.1.7 lineage, was initially detected in the UK and it carries a large number of genetic changes, with over ten mutations located in the spike protein.

The new results found that antibodies in the blood of 16 patients who had been vaccinated with the Pfizer/BioNTech jab, also known as BNT162b2, were able to neutralise an in vitro version of the new variant.

“The preserved neutralisation of the pseudovirus bearing the UK strain spike by BNT162b2-immune sera [blood] makes it likely that COVID-19 caused by the UK virus variant will also be prevented by immunisation with BNT162b2,” the companies said in a statement.

Although the results have not yet been peer-reviewed, Pfizer and BioNTech said that they were ‘encouraged’ by the early study findings.

The companies also acknowledged the possibility of altering the vaccine strain to address virus variants in the future, adding that they are confident in the flexibility of BioNTech’s mRNA vaccine platform.

The Pfizer/BioNTech vaccine was authorised for emergency use by the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK in December.

Pfizer/BioNTech signed an agreement with the UK last July to supply 30 million doses of BNT162b2 upon its approval, which was further increased to 40 million in October.

As of 19 January, more than four million people in the UK have received their first dose of a COVID-19 vaccine, including more than half of those aged 80 years and over and more than half of all elderly care home residents.